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OP021
Efficacy and safety of oral tofacitinib for maintenance therapy in patients with moderate-to-severe Crohn’s disease: results of a Phase 2b randomised placebo-controlled trial
G. D’Haens*1, R. Pannaccione2, P. D. R. Higgins3, J.-F. Colombel3, B. G. Feagan4, M. Moscariello5, G. Chan5, P. Healey6, W. Niezychowski5, W. Wang5, A. Marren5, E. Maller5
1Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands, 2University of Calgary, Calgary, Canada, 3University of Michigan, Ann Arbor, Michigan, United States, 4Robarts Research Institute, London, Ontario, Canada, 5Pfizer Inc, Collegeville, Pennsylvania, United States, 6Pfizer Inc, Groton, Connecticut, United States
OP022
Efficacy and safety of oral tofacitinib for induction therapy in patients with moderate-to-severe Crohn’s disease: results of a Phase 2b randomised placebo-controlled trial
J. Panés*1, W. J. Sandborn2, S. Schreiber3, B. E. Sands4, S. Vermeire5, G. Chan6, M. Moscariello6, W. Wang6, W. Niezychowski6, A. Marren6, P. Healey7, E. Maller6
1Hospital Clinicas de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, 2Division of Gastroenterology, University of California, San Diego, United States, 3Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany, 4Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, United States, 5Dept of Gastroenterology, University Hospitals Leuven, Leuven, Belgium, 6Pfizer Inc, Collegeville, United States, 7Pfizer Inc, Groton, United States
OP023
Comparison between newly developed narrow band imaging and panchromoendoscopy for surveillance colonoscopy in patients with ulcerative colitis: a prospective multicentre randomised controlled trial, navigator study
K. Watanabe*1, M. Nishishita2, F. Shimamoto3, T. Fukuchi4, M. Esaki5, Y. Okamoto5, Y. Maehata5, S. Oka6, S. Nishiyama6, S. Fujii7, F. Hirai8, T. Inoue9, N. Hida10, R. Nozaki11, T. Sakurai12, K. Takeuchi13, M. Saruta14, S. Saito15, Y. Saito16, N. Ohmiya17, H. Kashida12, S. Tanaka6, T. Matsui8, Y. Suzuki18, Y. Ajioka19, H. Tajiri20
1Osaka City General Hospital, Gastroenterology, Osaka, Japan, 2Nishishita Gastrointestinal Hospital, Osaka, Japan, 3Faculty of Human Culture and Science Prefectural University of Hiroshima, Hiroshima, Japan, 4Osakafu Saiseikai Nakatsu Hospital, Gastroenterology and Hepatology, Osaka, Japan, 5Graduate School of Medical Sciences, Kyushu University, Department of Medicine and Clinical Science, Fukuoka, Japan, 6Hiroshima University Hospital, Department of Endoscopy, Hiroshima, Japan, 7Kyoto Katsura Hospital, Digestive Disease Centre, Department of Gastroenterology, Kyoto, Japan, 8Fukuoka University Chikushi Hospital, Department of Gastroenterology, Fukuoka, Japan, 9Osaka Medical College, Second Department of Internal Medicine, Osaka, Japan, 10Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Hyogo, Japan, 11Takano Hospital, Division of Gastroenterology, Coloproctology Centre, Kumamoto, Japan, 12Kinki University, Department of Gastroenterology, Osaka, Japan, 13Toho University Sakura Medical Centre, Department of Internal Medicin, Chiba, Japan, 14The Jikei University School of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo, Japan, 15The Jikei University School of Medicine, Department of Endoscopy, Tokyo, Japan, 16National Cancer Centre Hospital, Endoscopy Division, Tokyo, Japan, 17School of Medicine, Fujita Health University, Department of Gastroenterology, Aichi, Japan, 18Toho University Sakura Medical Centre, Department of Internal Medicine, Chiba, Japan, 19Graduate School of Medical and Dental Sciences, Niigata University, Division of Molecular and Diagnostic Pathology, Niigata, Japan, 20The Jikei University School of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Department of Endoscopy, Tokyo, Japan
OP024
Mucosal healing and dysplasia surveillance in a large referral Centre cohort of patients with Crohn’s disease and ulcerative colitis treated with vedolizumab
M. Noman1, M. Ferrante1, R. Bisschops1, G. De Hertogh2, K. Van Den Broeck1, K. Rans1, P. Rutgeerts1, S. Vermeire1, G. Van Assche*1
1UZ Leuven, Gastroenterology, Leuven, Belgium, 2UZ Leuven, Campus Gasthuisberg, Pathology, Leuven, Belgium
OP025
Escalation of medical therapy decreases need for repeat dilatation in Crohn’s anastomatic strictures
N. S. Ding*1, 2, W. Yip1, R. Choi1, B. Saunders3, S. Thomas-Gibson3, N. Arebi1, A. Humphries3, A. Hart1
1St Mark’s Hospital, IBD, London, United Kingdom, 2Imperial College London, Department of Surgery and Cancer, London, United Kingdom, 3St Mark’s Hospital, Wolfson Unit For Endoscopy, Department of Gastroenterology, Harrow, United Kingdom
OP026
The TOPPIC Trial: a randomised, double-blind parallel-group trial of mercaptopurine versus placebo to prevent recurrence of Crohn’s disease following surgical resection in 240 patients
I. Arnott1, C. Mowat2, H. Ennis3, C. Keerie3, S. Lewis3, N. Kennedy4, A. Cahill5, A. Morris5, M. Dunlop6, S. Bloom7, J. Lindsay8, S. Subramanian9, J. Satsangi*4, TOPPIC Trial Study Group10
1NHS Lothian, Gastroenterology, Edinburgh, United Kingdom, 2NHS Tayside, Gastroenterology, Dundee, United Kingdom, 3University of Edinburgh, Edinburgh Clinical Trials Unit, Edinburgh, United Kingdom, 4University of Edinburgh, Gastroenterology, Edinburgh, United Kingdom, 5NHS Greater Glasgow and Clyde, Gastroenterology, Glasgow, United Kingdom, 6University of Edinburgh, Institute of Genetics and Molecular Medicine, Edinburgh, United Kingdom, 7University College Hospital, Department of Gastroenterology, London, United Kingdom, 8Bart’s Health NHS Trust, Newham University Hospital, Department of Gastroenterology, London, United Kingdom, 9Royal Liverpool University Hospital, Gastroenterology, Liverpool, United Kingdom, 10Toppic Trial Study Group, UK, United Kingdom
OP027
Anti-tumour necrosis factor therapy is associated with increased risk of postoperative morbidity after surgery for ileocolonic Crohn’s disease: outcome analysis in a prospective nationwide cohort of 592 patients conducted by the GETAID chirurgie group
A. Brouquet*1, L. Maggiori2, P. Zerbib3, J. Lefèvre4, Q. Denost5, A. Germain6, E. Cotte7, L. Beyer-Berjot8, N. Munoz-Bongrand9, V. Desfourneaux10, A. Rahili11, J.-P. Duffas12, K. Pautrat13, C. Denet14, V. Bridoux15, G. Meurette16, J.-L. Faucheron17, J. Loriau18, F. Guillon19, E. Vicaut20, S. Benoist1, Y. Panis2
1Bicêtre Hospital - Université Paris Sud, Oncologic and Digestive Surgery, Le Kremlin-Bicêtre, France, 2Beajon Hospital, Colorectal Surgery, Clichy, France, 3CHU Lille, Digestive Surgery, Lille, France, 4Saint Antoine Hospital, Digestive Surgery, Paris, France, 5CHU Bordeaux, Digestive Surgery, Bordeaux, France, 6CHU Nancy, Digestive Surgery, Nancy, France, 7CHU Lyon-Sud, Digestive Surgery, Lyon, France, 8CHU Marseille, Digestive Surgery, Marseille, France, 9Saint Louis Hospital, Digestive Surgery, Paris, France, 10CHU Rennes, Digestive Surgery, Rennes, France, 11CHU Nice, Digestive Surgery, Nice, France, 12CHU Toulouse, Digestive Surgery, Toulouse, France, 13Lariboisière Hospital, Digestive Surgery, Paris, France, 14Montsouris insitute, Digestive Surgery, Paris, France, 15CHU Rouen, Digestive Surgery, Rouen, France, 16CHU Nantes, Digestive Surgery, Nantes, France, 17CHU Grenoble, Digestive Surgery, Grenoble, France, 18Saint-Joseph Hospital, Digestive Surgery, Paris, France, 19CHU Montpellier, Digestive Surgery, Montpellier, France, 20Fernand Widal Hospital, Clinical research, Paris, France
OP028
Pharmacokinetics and exposure-response relationships of intravenously administered ustekinumab during induction treatment in patients with Crohn’s disease: results from the UNITI-1 and UNITI-2 studies
O. J. Adedokun*1, Z. Xu1, C. Gasink1, J. Friedman1, P. Szapary1, Y. Lang1, J. Johanns1, L.-L. Gao1, Y. Miao1, H. Davis1, S. Hanauer2, B. Feagan3, W. Sandborn4
1Janssen R & D, LLC, Spring House, Pennsylvania, United States, 2Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, 3Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, Ontario, Canada, 4UCSD, Medicine, La Jolla, California, United States
OP029
Drug-concentration versus symptom-driven dose adaptation of Infliximab in patients with active Crohn’s disease: a prospective, randomised, multicentre trial (Tailorix)
G. D’Haens*1, S. Vermeire2, G. Lambrecht3, F. Baert4, P. Bossuyt5, M. Nachury6, A. Buisson7, Y. Bouhnik8, J. Filippi9, J. vande Woude10, P. Van Hootegem11, J. Moreau12, E. Louis13, D. Franchimont14, M. De Vos15, F. Mana16, L. Peyrin-Biroulet17, H. Brixi18, M. Allez19, P. Caenepeel20, A. Aubourg21, B. Oldenburg22, M. Pierik23, A. Gils24, S. Chevret25, D. Laharie26
1Academic Medical Centre, Gastroenterology, Amsterdam, Netherlands, 2University Hospitals Gasthuisberg, Gastroenterology, Leuven, Belgium, 3AZ Damiaan, Oostende, Belgium, 4AZ Delta, Roeselare, Belgium, 5Imelda GI Clinical Research Centre, Bonheiden, Belgium, 6Hopital Claude Hurriez, Lille, France, 7Hopital Estaing, Clermont-Ferrand, France, 8Hopital Beaujon, Clichy, France, 9Hospital Archet, Nice, France, 10Erasmus Medical Centre, Rotterdam, Netherlands, 11St Lukas Hospital, Bruges, Belgium, 12Hopital Rangueil, Toulouse, France, 13Hopital Sart Tilman, Liège, Belgium, 14Hopital Erasme, Brussels, Belgium, 15University of Ghent, Ghent, Belgium, 16Free University of Brussels, Brussels, Belgium, 17Hopital Brabois, Nancy, France, 18Hopital Robert Debre, Reims, France, 19Hopital St Louis, Paris, France, 20Ziekenhuis Oost Limburg, Genk, Belgium, 21Hopital Trousseau, Tours, France, 22University of Utrecht, Utrecht, Netherlands, 23University Hospital Maastricht, Maastricht, Netherlands, 24University of Leuven, Leuven, Belgium, 25Dept Biostatistique St Louis, Paris, France, 26Haut-Leveque, Pessac, France
The most potent available treatment for active Crohn’s disease (CD) is a combination of infliximab (IFX) and azathioprine, leading to disappearance of ulcerations in up to 50% of patients. Because superior outcomes have been associated with serum drug concentrations within what is considered a ‘therapeutic window’, we hypothesised that prospective therapeutic drug monitoring (TDM) would lead to higher remission rates as compared with pure symptom-based dose adaptations.
This was a prospective randomised, double-blinded, multicentre controlled trial in which biologic naïve adult patients with active CD (CDAI > 220, serum CRP > 5 mg/L, and/or faecal calprotectin > 250 µg/g and endoscopic ulcerations) received induction treatment with 3 infusions of IFX 5 mg/kg in combination with azathioprine 2–2.,5 mg/kg/day or MTX in case of intolerance. At week 14, patients were randomised to 1 of 3 different maintenance strategies: 1) dose intensification of IFX in (maximally 2) steps of 2,5 mg/kg based on clinical symptoms, biomarker analysis and serum IFX concentrations drawn before the previous infusion (group 1); 2) dose intensification of IFX from 5 to 10 mg/kg based on the same criteria (group 2), and 3) IFX dose increase to 10 mg/kg based on clinical symptoms alone (group 3). The primary endpoint of the trial was sustained steroid-free clinical remission from week 22 to -54 and absence of ulceration at 1 year based on centrally read endoscopies. Target for IFX dosing was a trough concentration > 3 ug/ml. (EUDRACT NUMBER: 2011-003038-14)
At 27 sites in Belgium, France, and the Netherlands,167 patients were screened, and 122 were randomised (71 F, median age 29.8 years). The 3 groups had comparable patient characteristics. The primary endpoint based on local endoscopy reads was attained in 21/45 (47%) in group 1, 14/37 (38%) in group 2, and 16/40 (40%) in group 3 (p = NS). The proportions of patients without ulcerations at week 54 were 36%, 43%, and 48% (p = NS) and with endoscopic remission (CDEIS < 3) 49%, 51%, and 45% (p = NS). Dose intensification was done in 51%, 65%, and 40% of the patients.
In this prospective randomised exploratory trial in patients with active CD, proactive trough-level–based dose intensification was not superior to dose intensification based on symptoms alone. Results with centrally read endoscopy are being awaited, as well as detailed pharmacokinetic, immunogenicity, and biomarker analysis. More benefit from TDM may be obtained during induction and in dose reduction efforts, which was not studied in this trial.
OP030
Factors associated with the first trough level of infliximab at week 2 that predicts short- and long-term outcomes in ulcerative colitis
T. Kobayashi*1, Y. Suzuki2, S. Motoya3, F. Hirai4, H. Ogata5, H. Ito6, N. Sato7, K. Ozaki7, M. Watanabe8, T. Hibi1
1Kitasato University Kitasato Institute Hospital, Centre for Advanced IBD Research and Treatment, Tokyo, Japan, 2Toho University Sakura Medical Centre, Department of Internal Medicine, Sakura, Japan, 3Sapporo-kosei General Hospital, Inflammatory Bowel Diseases Centre, Sapporo, Japan, 4Fukuoka University Chikushi Hospital, Department of Gastroenterology, Chikushino, Japan, 5Keio University School of Medicine, Centre for Diagnostic and Therapeutic Endoscopy, Tokyo, Japan, 6Kitano Hospital The Tazuke Kofukai Medical Research Institute, Digestive Disease Centre, Osaka, Japan, 7Mitsubishi Tanabe Pharma Corporation, Osaka, Japan, 8Tokyo Medical and Dental University, Department of Gastroenterology and Hepatology, Tokyo, Japan
P001
Comparison of in vivo T cell homing to the inflamed gut with the etrolizumab surrogate antibody FIB504 and vedolizumab in a humanised mouse model
S. Zundler*, A. Fischer, R. Atreya, C. Neufert, I. Atreya, M. F. Neurath
University of Erlangen-Nuremberg, Department of Medicine I, Erlangen, Germany
P002
Beneficial effects of blocking EphBs-ephrinBs forward signalling in a murine Crohn’s sisease (CD) model
A. Grandi, I. Zini, M. Tognolini, V. Ballabeni, E. Barocelli, S. Bertoni*
University of Parma, Department of Pharmacy, Parma, Italy
P003
Activation of endoplasmic reticulum stress in the intestinal mucosa of Crohn’s disease patients
A. Coope*1, J. D. Botezelli2, M. L. S. Ayrizono1, L. A. Velloso3, R. F. Leal1
1University of Campinas, Coloproctology Unit, Surgery Department, Campinas, Brazil, 2University of Campinas, Campinas, Brazil, 3University of Campinas, Laboratory of Cell Signalling, Internal Medicine Department, Campinas, Brazil
P004
Exon-level microarrays identify alternative splicing for ICAM3 in Crohn’s disease
S. Verstockt*1, M. Vancamelbeke2, B. Verstockt2, F. Schuit3, M. Ferrante2, S. Vermeire2, I. Cleynen1, I. Arijs2
1KU Leuven, Department of Human Genetics, Leuven, Belgium, 2KU Leuven, Department of Clinical and Experimental Medicine, Translational Research Centre for Gastrointestinal Disorders, Leuven, Belgium, 3KU Leuven, Department of Cellular and Molecular Medicine, Gene Expression Unit, Leuven, Belgium
P005
Variability in Vedolizumab Exposure between Patients with Inflammatory Bowel Disease
A. Gils1, E. Dreesen*1, M. Peeters1, E. Brouwers1, M. Ferrante2, G. Van Assche2, S. Vermeire2
1KU Leuven, P.O. Box 820 Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium, 2KU Leuven, P.O. Box 7003, Department of Clinical and Experimental Medicine, Leuven, Belgium
P006
Correlation of small intestinal permeability, faecal calprotectin and barrier genes in multiple-affected families with inflammatory bowel disease
M. Vancamelbeke*1, V. Ballet1, A. Luypaerts1, T. Vanuytsel1, M. Ferrante1, R. Farré1, K. Verbeke1, S. Vermeire1, I. Cleynen2
1University Hospitals Leuven - KU Leuven, Department of Clinical and Experimental Medicine, Translational Research Centre for Gastrointestinal Disorders (TARGID), Leuven, Belgium, 2KU Leuven, Department of Human Genetics, Leuven, Belgium
P007
IL-36 α expression is elevated in ulcerative colitis and promotes colonic inflammation
S. E. Russell1, 2, R. M. Horan1, 2, A. M. Stefanska1, 2, A. Carey1, 2, G. Leon2, M. Aguilera3, D. Statovci3, T. Moran2, P. G. Fallon2, F. Shanahan3, E. K. Brint4, S. Melgar*3, S. Hussey2, 5, P. T. Walsh1, 2
1Trinity College Dublin, Dublin, Ireland, 2National Children’s Research Centre, Our Lady’s Children Hospital, Dublin, Ireland, 3University College Cork, APC Microbiome Institute, Cork, Ireland, 4University College Cork, Department of Pathology, Cork, Ireland, 5University College Dublin, Academic Centre for Paediatric Research, Dublin, Ireland
P008
Targeting of TSLP by miR-31 may play an important role in mucosal healing, in ulcerative colitis.
S. Whiteoak*1, 2, A. Claridge1, 3, T. Sanchez-Elsner*1, J. F. Cummings2
1University of Southampton, Clinical and Experimental Sciences, Southampton, United Kingdom, 2University of Southampton, Department of Gastroenterology, Southampton, United Kingdom, 3Great Western Hospitals NHS Foundation Trust, Department of Gastroenterology, Swindon, United Kingdom
P009
Lipid biomarkers to diagnose Crohn’s disease using metabonomic profiling approach in serum and faeces.
N. S. Ding*1, 2, M. Sarafian1, 2, R. Misra1, P. Hendy1, L. Penez1, E. Holmes2, A. Hart1
1St Mark’s Hospital, IBD, London, United Kingdom, 2Imperial College London, Department of Surgery and Cancer, London, United Kingdom
P010
Infliximab skews macrophages towards an IL10-high/IL12p40-low phenotype in an Fc region dependent manner
F. Bloemendaal*1, M. Wildenberg1, A. Levin1, P. Koelink1, A.C. Vos2, G. D’Haens1, G. van den Brink1
1Academic Medical Centre, Gastroenterology, Amsterdam, Netherlands, 2Leiden University Medical Centre, Gastroenterology, Leiden, Netherlands